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10 G CERTIFICATION

Published on 09 23, 2013

It’s a few years now that we have frequently been making reference to the EN 1865-1 and the EN 1789 which specifies requirements for the design, testing, performance and equipping of road ambulances used for the transport and care of patients.

The EN 1865-1 defines the essentialdesigns and project requirementsfor the stretchers and other equipment for the transport of patientsin the roadambulance.

The EN 1789 defines the requirements for the design, testing, performance and equipping of road ambulances used for the transport and care of patients. It states the general requirements for the Medical Devices to be used on and outside the ambulance vehicle out of the hospital or clinic structure and in situations and environmental conditions that could of course be significantly different to those normally found in within the standard structures.

Considerable attention and importance is given to the requirements of conformity of both the device and its fixing structure which must be able hold the device and withstand the force of acceleration and deceleration of 10 G in both longitudinal (back and forwards),transversal (left to right) and in a 10G vertical drop.

Point 4.5.9 of the UNI EN 1789 specifies that “all the people and items such as Medical Devices, tools and items commonly used onboard the ambulance must be stored, installed or held in such a way as to prevent them becoming bullets in the case of acceleration /deceleration with a force of up to 10G forwards, backwards, vertically or transversally.

On testing, the whole product should not have caused any damage to persons inside the ambulance and the patient should not move more than 150mm.

The tests for conformity to point 4.5.9 have to be confirmed by the use of calculation, by static testsor by dynamic tests (point 5.3 norm EN 1789). The norm states that whatever method used to test, it must be approved by an authorized body, and that is by a Government authority, based on the directive 70/156/CEE (article 14) – 77/541/CEE – 74/408/CEE – 96/79/CEE.

The Manufacturer therefore has thepossibility to choose if:

a)To have each single device tested by a third party

b)To have a test method approved by a third party so the tests can then be carried out on each single device

In each case, it is essential that the approval is given by parties authorized for the above Directives.

The normative is not limited only to the 10G compliancy of the stretchers; it is extended to ALL THE ITEMS and therefore all the medical devices considering that in case of impact, any item is potentially a danger for the safety of those on board the ambulance. An ambulance therefore, no matter what its function is, in order to be homologated 10G must first of all be equipped with devices that will withstand acceleration and deceleration of 10G.

This is the reason why Spencer Italia has a special team within the Technical Department dedicated to the research, design and developmentof devices with their relative fixing units with the characteristics stipulated in the normative.

Theambitious goal of Spencer Italia S.r.l has once again been met:

We are the first company in the world able to offer an ample assortment of products with their relative fixing units, certified to the 10G standard; just a few examples are our IV holders, Cylinder holders, Chairs, mattresses and Sphygmomanometersetc.

But Spencer hasn’t stopped there and has decided to go a step even further by demonstrating we are able to produce devices which resist to an impact of 20G. Many devices, among which are the stretchers and their fixing systems have been subjected with brilliant results to a 20G impact test and even after this type of impact, no structural damage was suffered.

We are not stopping here. Work is continuing now to update to the same 20G success also those devices which already have the 10G certification.

Our mission is to share with our clients the quality, safety and reliability that only Spencer products can guarantee.

Finally we have to remind you that the UNI EN 1789 does not cover the homologation or registrationrequirements of the vehicle or the training of the staff. This is the responsibility of the authorities of the country in which the ambulance is registered.